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Alnylam Issues 2nd Annual Patient Access Philosophy Report Highlighting Broad Access to the Company’s Approved Therapies

Alnylam Issues 2nd Annual Patient Access Philosophy Report Highlighting Broad Access to the Company’s Approved Therapies

− Company Also Introduces Inaugural ‘Rare Disease Trend Report’ Providing Insights Gleaned Through Interviews and Research with Payers −

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today published two new reports: the second annual update on its Patient Access Philosophy and its first-ever Rare Disease Trend Report. Together, the reports illuminate both the strategies by which the company has been able to maximize access for its approved medicines around the world, and the barriers associated with coverage for rare disease therapies.

The Patient Access Philosophy Report

The 2020 Patient Access Philosophy Report reflects Alnylam’s progress advancing its stated 2017 Patient Access Philosophy. The 2020 report highlights the Company’s efforts to support patients in gaining access to needed medicines, both before and during the COVID-19 pandemic. It also provides updates on initiatives to deliver strong value to payers in the face of increasing barriers to access for rare disease medicines.

Highlights include:

Rapid, affordable access to treatment: For people experiencing debilitating diseases like hATTR amyloidosis, acute hepatic porphyria or primary hyperoxaluria type 1, waiting for a therapy that could change their lives is unacceptable. In collaboration with payers around the world, Alnylam has:

  • Realized greater than 98% coverage for ONPATTRO and nearly 94% for GIVLAARI across U.S. commercial and government insurers, including Medicare and Medicaid.
  • Ensured the majority of commercially insured U.S. patients enrolled in its patient services program faced little to no out of pocket costs:

    • 75% of enrolled ONPATTRO patients and 87% of enrolled GIVLAARI patients have zero cost sharing for the medicine.
  • Achieved reimbursed access to ONPATTRO and GIVLAARI an average of 11 months faster than other orphan drugs in major European countries.
  • Established availability of ONPATTRO in more than 20 countries through direct reimbursement or expanded access.

Advocating for covered use of home administration: Travel to an infusion center or hospital to receive treatment can be challenging for some patients, especially during the COVID-19 pandemic. To support patients, Alnylam has advocated for insurers to cover home infusion, and today:

  • 20% of U.S. commercial patients on ONPATTRO and GIVLAARI are receiving treatment in the home.
  • Seven countries in the EU and Canada offer home administration with reimbursement for our medicines.

Executed nearly 30 value-based agreements (VBAs) with U.S. payers (ONPATTRO – 19; GIVLAARI – 10): Alnylam has pro-actively engaged with payers on VBAs to link reimbursement of its medicines with product performance and value delivered. VBAs represent a commitment to work with payers on business innovations that address the needs of patients. The company has also pioneered additional components for its VBA framework, including:

  • Prevalence-Based Adjustment (PBA) for its ultra-rare orphan disease products, where the company has committed to lower the price of its medicine if the number of patients identified within a plan population exceeds the expected disease prevalence.
  • Patient-Need Adjustment (PNA), where the company provides payers with greater budget certainty for medicines administered across a broad range of patient age groups. The company is applying this innovative PNA component in VBAs for OXLUMO.

“Three years ago, we set out to achieve what mattered to us: getting our RNAi therapeutics to those who can benefit from them and do it in a way that delivers value,” said John Maraganore, PhD, Chief Executive Officer of Alnylam. “As an increasing number of medicines become available to treat people with rare genetic diseases, insurers face challenges paying for them. We’ve engaged in innovative agreements that tie payments to health outcomes, or provide rebates when plans encounter more patients or higher drug usage than expected. Our healthcare system needs more pragmatic approaches such as these to ensure patients obtain access to needed therapies and that real value is delivered for the cost. We are very proud of our progress, and plan to continue to innovate and collaborate to ensure that patients have access to our medicines.”

Alnylam Rare Disease Trend Report

Critical to Alnylam’s strong market access results is a desire to understand the priorities of payers. The company is issuing its first U.S. Rare Disease Trend Report, resulting from interviews with 30 payer and plan decision-makers about barriers to rare disease access over a five-year horizon. The findings reveal increasing concern about the sustainability of expenditures on rare disease medicines and potential strategies that may be implemented to manage costs. As a leader in the advancement of innovative medicines for rare diseases, the company plans to conduct this survey, and issue an updated version of the report, annually.

Key findings:

  • Managing rare disease drug utilization. Payers express concern about the increased use and number of rare disease therapies and the associated rising costs. Current focus areas for therapeutic utilization management include central nervous system and respiratory medicines. Future areas of management may include digestive and bleeding disorder therapies.
  • Healthcare economic evidence: Payers believe metrics beyond clinical efficacy, such as healthcare economic evidence, must play an increasing role in how we value medicines. However, they note there is currently a dearth of this type of evidence, particularly for emerging therapies.
  • Risk-sharing: Approximately 50% of payers engage in innovative payment models for rare disease medicines today, but this is limited largely to oncology. Payers express interest in pursuing more outcomes-based contracts, but they cite operational obstacles such as administrative burden from data collection, data privacy concerns, interoperability of electronic health records and clarity on outcomes to track.

“This is a forward-looking report about how our healthcare system must continue to evolve and consider the mid-and long-term value of rare disease therapies for the benefit of patients, families and communities,” commented Shirley Bachman, Vice President, US Market Access at Alnylam. “Through open dialogue and collaboration with payers, we endeavor to find contracting solutions that mitigate risk and offer greater cost predictability. This helps ensure that payers can plan effectively and have greater confidence in covering our therapies for patients who need them.”

To read more about Alnylam’s global market access progress, download the full Patient Access Philosophy Report here. For those interested in reading more insights from payers on delivering access to rare and ultra-rare disease medicines, the inaugural Rare Disease Trend Report can be found here.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO™ (lumasiran). Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

Alnylam Forward Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including, without limitation, Alnylam’s views with respect to its progress advancing its stated 2017 Patient Access Philosophy, its efforts to support patients in gaining access to needed medicines, both before and during the COVID-19 pandemic, and initiatives to deliver strong value to payers in the face of increasing barriers to access for rare disease medicines, the Company’s plans to conduct a Rare Disease Trend survey, and issue an updated version of its Rare Disease Trend Report, annually, and expectations regarding the advancement of its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the COVID-19 global pandemic or any future pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses of rare diseases, initiation or continuation of treatment for diseases addressed by Alnylam products, or in patient enrollment in clinical trials, potential supply chain disruptions, and other potential impacts to Alnylam’s business, the effectiveness or timeliness of steps taken by Alnylam to mitigate the impact of the pandemic, and Alnylam’s ability to execute business continuity plans to address disruptions caused by the COVID-19 or any future pandemic; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all; actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing; delays, interruptions or failures in the manufacture and supply of its product candidates or its other marketed products; obtaining, maintaining and protecting intellectual property; intellectual property matters including potential patent litigation relating to its platform, products or product candidates; obtaining regulatory approval for its product candidates, and maintaining regulatory approval and obtaining pricing and reimbursement for its products, including ONPATTRO, GIVLAARI and OXLUMO; progress in continuing to establish an ex-United States infrastructure; successfully launching, marketing and selling its approved products globally, including ONPATTRO, GIVLAARI and OXLUMO, and achieving net product revenues for ONPATTRO within its revised expected range during 2020; Alnylam’s ability to successfully expand the indication for ONPATTRO in the future; competition from others using technology similar to Alnylam’s and others developing products for similar uses; Alnylam’s ability to manage its growth and operating expenses within the ranges of guidance provided by Alnylam through the implementation of further discipline in operations to moderate spend and its ability to achieve a self-sustainable financial profile in the future without the need for future equity financing; Alnylam’s ability to establish and maintain strategic business alliances and new business initiatives; Alnylam’s dependence on third parties, including Regeneron, for development, manufacture and distribution of certain products, including eye and CNS products, and Vir for the development of ALN-COV and other potential RNAi therapeutics targeting SARS-CoV-2 and host factors for SARS-CoV-2; the outcome of litigation; the risk of government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Alnylam Pharmaceuticals, Inc.

Christine Regan Lindenboom

(Investors and Media)

617-682-4340

Josh Brodsky

(Investors)

617-551-8276

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Infectious Diseases Genetics Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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AstroNova Reports Third-Quarter Fiscal 2021 Financial Results

AstroNova Reports Third-Quarter Fiscal 2021 Financial Results

  • Bookings of $27.9 million
  • Backlog of $23.2 million
  • Revenue of $28.0 million
  • Operating income of $0.4 million
  • Net income of $0.0 million, or $0.00 per diluted share
  • EBITDA of $1.7 million, or 6.1% of revenue

WEST WARWICK, R.I.–(BUSINESS WIRE)–
AstroNova, Inc. (NASDAQ: ALOT), a global leader in data visualization technologies, today announced financial results for the fiscal 2021 third quarter ended October 31, 2020.

“Our Product Identification segment delivered both revenue and margin improvements in the quarter while Test & Measurement continued to reflect the effects of the Boeing 737 MAX grounding and COVID-19 on the commercial aerospace industry,” said Greg Woods, AstroNova’s President and Chief Executive Officer. “Overall performance was aided by continuous improvement initiatives and reduced operating expenses. During the quarter we continued to invest in new products and technologies to support growth across our businesses.

“In Product Identification, strong demand from our TrojanLabel®, QuickLabel® and GetLabels® product lines drove year-on-year and sequential growth in both revenue and operating profit,” Woods said. “Our product and technology innovations are attracting a broader base of customers to our color label and specialty printing systems. We are helping businesses across a wide spectrum of industries enhance efficiency, eliminate waste and increase brand recognition.

“In our Test & Measurement segment, growth in our defense business partly offset weakness in commercial aerospace caused by the external headwinds. Looking ahead, recent progress on the potential approval of multiple coronavirus vaccines, and the FAA’s November decision that cleared the 737 MAX for a return to service, bode well for the T&M segment as we move through fiscal 2022 and beyond,” Woods concluded.

Q3 FY 2021 Operating Segment Results

Product Identification segment revenue was $22.9 million, compared with $21.7 million in the prior-year period. Segment operating income was $3.5 million, or 15.4% of revenue, compared with $1.9 million, or 8.6% of revenue, in the prior year, reflecting both increased efficiencies and reductions in operating costs.

Test & Measurement segment revenue was $5.1 million, compared with $11.6 million in the same period of fiscal 2020, due to the continued grounding of the Boeing 737 MAX and rapid demand falloff in the aerospace industry related to COVID-19. The Test & Measurement segment recorded an operating loss of $0.8 million, or negative 14.7% of revenue, compared with segment operating income of $1.4 million, or 12.1% of revenue, in the comparable period of fiscal 2020, a direct result of declines in aerospace printer sales and adverse mix, despite lower manufacturing and operating costs.

Hardware revenue dropped to $7.7 million, compared with $12.2 million in the prior-year period due to Test & Measurement weakness. Supplies revenue was $18.0 million versus $17.7 million in the same period of fiscal 2020. Service/other revenue was $2.4 million, compared with $3.5 million a year earlier.

Q3 FY 2021 Results Summary

Revenue totaled $28.0 million, compared with $33.3 million in the year-earlier period, with a decline in Test & Measurement revenue partly offset by higher revenue in the Product Identification segment.

Gross profit was $9.7 million, or 34.7% of revenue, compared with $12.3 million, or 36.9% of revenue, in the same period of fiscal 2020. The decrease reflected lower revenue and less favorable product mix in the 2021 period, primarily in the Test & Measurement segment.

Operating expenses totaled $9.3 million, down 21.4% compared with $11.9 million in the third quarter of fiscal 2020, reflecting the Company’s cost-reduction actions.

Operating income was $0.4 million in the third quarters of fiscal 2021 and 2020.

Other expense included foreign exchange losses resulting from the weaker Euro and Danish Kroner on exposures in those currencies and higher interest expense.

Net income was $12,000, or $0.00 per share, compared with net income of $0.5 million, or $0.06 per diluted share, for the third quarter of fiscal 2020.

Earnings before interest, taxes, depreciation, and amortization (EBITDA) were $1.7 million, compared with $2.0 million in the third quarter of fiscal 2020. EBITDA is a non-GAAP financial measure explained in greater detail below under “Use of Non-GAAP Financial Measure.” Please refer to the financial reconciliation table included in this news release for a reconciliation of EBITDA to net income for the fiscal third quarters ended October 31, 2020 and November 2, 2019.

Bookings were $27.9 million, compared with $32.6 million in the third quarter of fiscal 2020.

Backlog at October 31, 2020 was $23.2 million versus $20.8 million at the end of the fiscal 2020 third quarter.

Recent Highlights

  • AstroNova launched a range of new products that expanded its addressable market beyond label printing at the PACK EXPO Connects 2020 international packaging tradeshow. These products included the TrojanLabel T2-C Print and Apply Solution that eliminates intermediate steps in the typical labeling process. Also demonstrated were in-line barcode verification systems and label finishing systems.
  • AstroNova received an exclusive, multi-year commitment from a major North American air carrier to purchase the Company’s ToughWriter brand of narrow-format flight deck printers for the carrier’s Boeing 737 aircraft.

Q3 FY 2021 Conference Call

AstroNova will discuss its third-quarter fiscal 2021 financial results in an investor conference call at 9:00 a.m. ET today. To participate on the conference call, please dial (800) 367-2403 (U.S. and Canada) or (334) 777-6978 (International) approximately 10 minutes prior to the start time and enter confirmation code 2309769.

You can hear a replay of the conference call from 12:00 p.m. ET Monday, December 7, 2020 until 12:00 p.m. ET on Monday, December 14, 2020 by dialing (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International). The passcode is 2309769. A real-time and an archived audio webcast of the call will be available through the “Investors” section of the AstroNova website, https://investors.astronovainc.com.

Use of Non-GAAP Financial Measure

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this news release contains the non-GAAP financial measure earnings before interest, taxes, depreciation, and amortization (EBITDA). AstroNova believes that the inclusion of this non-GAAP financial measure helps investors gain a meaningful understanding of changes in the Company’s core operating results, and also can help investors who wish to make comparisons between AstroNova and other companies on both a GAAP and a non-GAAP basis. AstroNova’s management uses EBITDA, in addition to GAAP financial measures, as the basis for measuring its core operating performance and comparing such performance to that of prior periods and to the performance of its competitors. EBITDA also is used by the Company’s management to assist with their financial and operating decision-making.

About AstroNova

AstroNova, Inc. (NASDAQ: ALOT), a global leader in data visualization technologies since 1969, designs, manufactures, distributes, and services a broad range of products that acquire, store, analyze, and present data in multiple formats. The Product Identification segment offers a complete line-up of labeling hardware and supplies, allowing customers to mark, track, and enhance their products’ appearance. The segment is comprised of three business units: QuickLabel®, the industry leader in tabletop digital color label printing; TrojanLabel®, an innovative leader for professional label presses; and GetLabels™, the premier supplier of label materials, inks, toners, ribbons, and adhesives, all compatible with the major printer brands. Supported by AstroNova’s customer application experts and technology leadership in printing, material science, and high-speed data processing, customers benefit from an optimized, “total solution” approach. The Test and Measurement segment includes the AstroNova Aerospace business unit, which designs and manufactures flight deck printers, networking hardware, and related accessories serving the world’s aerospace and defense industries with proven advanced airborne technology solutions for the cockpit and the cabin; and the Test and Measurement business unit, which offers a suite of products and services that acquire, record, and analyze electronic signal data from local and networked sensors. AstroNova is a member of the Russell Microcap® Index and the LD Micro Index (INDEXNYSEGIS: LDMICRO). Additional information is available by visiting www.astronovainc.com.

Forward-Looking Statements

Information included in this news release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact but rather reflect our current expectations concerning future events and results. These statements may include the use of the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “continues,” “may,” “will,” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning the Company’s anticipated performance, clearance of the 737 MAX to return to service, and the potential approval of a coronavirus vaccine, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended January 31, 2020 and subsequent filings AstroNova makes with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The reader is cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this news release.

ASTRONOVA, INC.
Condensed Consolidated Statements of Income
In Thousands Except for Per Share Data
(Unaudited)
 
Three Months Ended Nine Months Ended

October 31, 2020

 

November 2, 2019

 

October 31, 2020

 

November 2, 2019

Net Revenue

$

28,017

$

33,318

$

86,595

$

102,967

Cost of Revenue

 

18,282

 

21,021

 

56,218

 

64,454

Gross Profit

 

9,735

 

12,297

 

30,377

 

38,513

Total Gross Profit Margin

 

34.7%

 

36.9%

 

35.1%

 

37.4%
Operating Expenses:
Selling & Marketing

 

5,553

 

6,944

 

17,033

 

20,122

Research & Development

 

1,412

 

2,076

 

4,845

 

5,868

General & Administrative

 

2,353

 

2,830

 

7,214

 

8,445

Total Operating Expenses

 

9,318

 

11,850

 

29,092

 

34,435

Operating Income

 

417

 

447

 

1,285

 

4,078

Total Operating Margin

 

1.5%

 

1.3%

 

1.5%

 

4.0%
Other Expense, net

 

437

 

238

 

459

 

788

Income (Loss) Before Taxes

 

(20)

 

209

 

826

 

3,290

Income Tax (Benefit) Provision

 

(32)

 

(247)

 

379

 

182

Net Income

$

12

$

456

$

447

$

3,108

Net Income per Common Share – Basic

$

0.00

$

0.06

$

0.06

$

0.44

Net Income per Common Share – Diluted

$

0.00

$

0.06

$

0.06

$

0.43

 
Weighted Average Number of Common Shares – Basic

 

7,120

 

7,047

 

7,100

 

7,013

Weighted Average Number of Common Shares – Diluted

 

7,185

 

7,199

 

7,137

 

7,272

 
ASTRONOVA, INC.
Balance Sheet
In Thousands
(Unaudited)
 

October 31, 2020

 

January 31, 2020

 
ASSETS
CURRENT ASSETS
Cash and Cash Equivalents

$

9,603

$

4,249

Accounts Receivable, net

 

15,662

 

19,784

Inventories, net

 

30,868

 

33,925

Prepaid Expenses and Other Current Assets

 

2,769

 

2,193

Total Current Assets

 

58,902

 

60,151

PROPERTY, PLANT AND EQUIPMENT

 

50,252

 

48,046

Less Accumulated Depreciation

 

(38,308)

 

(36,778)

Property, Plant and Equipment, net

 

11,944

 

11,268

OTHER ASSETS
Intangible Assets, net

 

22,413

 

25,383

Goodwill

 

12,466

 

12,034

Deferred Tax Assets

 

5,099

 

5,079

Right of Use Asset

 

1,436

 

1,661

Other Assets

 

1,049

 

1,088

TOTAL ASSETS

$

113,309

$

116,664

LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts Payable

$

4,825

$

4,409

Accrued Compensation

 

2,749

 

2,700

Other Liabilities and Accrued Expenses

 

3,481

 

4,711

Current Portion of Long-Term Debt

 

4,984

 

5,208

Revolving Credit Facility

 

–

 

6,500

Current Portion of Royalty Obligation

 

2,000

 

2,000

Current Liability – Excess Royalty Payment Due

 

147

 

773

Deferred Revenue

 

313

 

466

Total Current Liabilities

 

18,499

 

26,767

NON-CURRENT LIABILITIES
Long-Term Debt, net of current portion

 

8,488

 

7,715

Royalty Obligation, net of current portion

 

6,624

 

8,012

Long-Term Debt – PPP Loan

 

4,422

 

–

Lease Liability, net of current portion

 

1,105

 

1,279

Other Long-Term Liabilities

 

657

 

1,081

Deferred Tax Liabilities

 

476

 

435

TOTAL LIABILITIES

 

40,271

 

45,289

SHAREHOLDERS’ EQUITY
Common Stock

 

521

 

517

Additional Paid-in Capital

 

57,894

 

56,130

Retained Earnings

 

49,248

 

49,298

Treasury Stock

 

(33,568)

 

(33,477)

Accumulated Other Comprehensive Loss, net of tax

 

(1,057)

 

(1,093)

TOTAL SHAREHOLDERS’ EQUITY

 

73,038

 

71,375

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$

113,309

$

116,664

 
ASTRONOVA, INC.
Revenue and Segment Operating Profit
In Thousands
(Unaudited)
 
Revenue Segment Operating Profit (Loss) Revenue Segment Operating Profit (Loss)
Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended

October 31, 2020

November 2, 2019

October 31, 2020

November 2, 2019

 

October 31, 2020

November 2, 2019

October 31, 2020

November 2, 2019

Product Identification

$

22,898

$

21,749

$

3,521

$

1,880

$

66,907

$

67,484

$

9,813

$

6,990

Test & Measurement

 

5,119

 

11,569

 

(751)

 

1,397

 

19,688

 

35,483

 

(1,314)

 

5,533

Total

$

28,017

$

33,318

 

2,770

 

3,277

$

86,595

$

102,967

 

8,499

 

12,523

Corporate Expenses

 

2,353

 

2,830

 

7,214

 

8,445

Operating Income

 

417

 

447

 

1,285

 

4,078

Other Expense, net

 

437

 

238

 

459

 

788

Income (Loss) Before Income Taxes

 

(20)

 

209

 

826

 

3,290

Income Tax (Benefit) Provision

 

(32)

 

(247)

 

379

 

182

Net Income

$

12

$

456

$

447

$

3,108

 
ASTRONOVA, INC.
Reconciliation of Net Income to EBITDA
Amounts in Thousands
(Unaudited)
 
Three Months Ended Nine Months Ended

October 31, 2020

 

November 2, 2019

 

October 31, 2020

 

November 2, 2019

Net Income − GAAP

$

12

$

456

$

447

$

3,108

Interest Income

 

(3)

 

(1)

 

(6)

 

(4)

Interest Expense

 

286

 

206

 

707

 

513

Income Tax Expense

 

(32)

 

(247)

 

379

 

182

Depreciation/Amortization

 

1,438

 

1,550

 

4,572

 

4,692

EBITDA

$

1,701

$

1,964

$

6,099

$

8,491

 

 

Scott Solomon

Senior Vice President

Sharon Merrill Associates

(617) 542-5300

[email protected]

KEYWORDS: Rhode Island United States North America

INDUSTRY KEYWORDS: Technology Packaging Hardware Manufacturing

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Agile Therapeutics Announces Nationwide Commercial Launch and Availability of Twirla® (levonorgestrel and ethinyl estradiol) Transdermal System, a New Non-Daily, Non-Invasive Contraceptive Patch

Once-Weekly
Twirla is the first and only contraceptive patch that combines levonorgestrel and ethinyl estradiol (EE)

PRINCETON, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced the U.S. commercial launch of Twirla® (levonorgestrel and ethinyl estradiol) transdermal system, a new non-daily, non-invasive contraceptive patch. Twirla is now available in the United States by prescription for women of reproductive potential with a body mass index (BMI) <30 kg/m2 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. Twirla is less effective in women with a BMI ≥ 25 kg/m2 to < 30 kg/m2 and should not be used in women with a BMI ≥ 30 kg/m2.  

Please see Important Safety Information for Twirla, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI ≥ 30 kg/m2, below in “About Twirla.” In a clinical trial, the most common adverse events were skin reactions at the patch site, nausea, headache, menstrual cramps, and weight gain.

“We are thrilled to launch our first commercial product, Twirla, an effective, modern contraceptive option, for women and their healthcare providers,” said Al Altomari, Chairman and Chief Executive Officer of Agile. “Family planning experts believe the most successful contraception for a woman is one of her choosing that fits her lifestyle, and we believe Twirla will be a valuable addition to the category’s available options. We are committed to seeking ways to make Twirla affordable and accessible for women.”

Twirla is worn weekly and delivers a 30 mcg daily dose of ethinyl estradiol, the lowest exposure of estrogen in a transdermal contraceptive option1, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history of use in the category. Twirla is designed to be worn on the abdomen, buttock, or upper torso (excluding the breasts), using Skinfusion® technology. At less than 1mm thin, Twirla is made up of five distinct layers for focused drug delivery and to help maintain adhesion.   

“Nearly all women use contraception at some point in their lives, but when it comes to preventing unplanned pregnancies, 90% of failures are attributed to inconsistent and/or improper use,” said Donnica Moore, MD, women’s health expert and advocate, President, Sapphire Women’s Health Group and consultant to Agile Therapeutics. “Today, women need a birth control product that is not only safe and reliable, but also that fits seamlessly into an active lifestyle. The soft and flexible design of Twirla contours to a woman’s body, requires no invasive procedures, and reduces the burden of daily administration. I am excited that healthcare providers can now offer a new solution that can fill a gap in hormonal contraceptive care.”

“The approach that we have taken in the development and launch of Twirla is representative of Agile’s ongoing dedication to addressing the unmet needs of today’s women,” said Paul Korner, MD, MBA, Chief Medical Officer of Agile. “Not only did we design our Phase 3 trial to closely represent the U.S. demographics of women, but we also worked with women over the last four years to better understand their evolving needs to ensure our patient programs holistically support women who use Twirla.”

To provide women with additional personalized resources, Agile has introduced an insight-driven experience, called The Loop (http://www.Twirla.com/TheLoop). The Loop will serve as an online destination where women can get meaningful resources as they navigate their birth control journeys. Twirla patients can access the Twirla patch replacement program, chat with qualified nurse-educators about patch use, and read specially curated content designed to inspire Twirla women beyond the brand. The Loop is designed to create a sense of community by bringing together and celebrating women who embody the Twirla spirit of courage and confidence.

Women who would like to learn more about Twirla as a potential contraceptive option should speak to their doctor or a healthcare provider. For more information on Twirla, consumers and healthcare providers can visit www.Twirla.com.

1Xulane [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals; 2020.  

About Twirla

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 KG/M

2
 

Cigarette Smoking and Serious Cardiovascular Events
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.
 

Contraindicated in Women with a BMI ≥ 30 kg/m



2
TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m

2

. Compared to women with a lower BMI, women with a BMI ≥ 30 kg/m

2

had reduced effectiveness and may have a higher risk for venous thromboembolism events (VTEs).

CONTRAINDICATIONS
TWIRLA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic disease, including women with a BMI ≥ 30 kg/m2; have headaches with focal neurological symptoms, migraine with aura, women over 35 years of age with any migraine headache; liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; hypersensitivity to any components of TWIRLA; and use of Hepatitis C drug combinations containing ombitasvir/paraparesis/ritonavir with or without dasabuvir.

WARNINGS AND PRECAUTIONS

  • Thromboembolic Disorders and Other Vascular Conditions-
    Women are at increased risk for a venous thromboembolic event (VTE) when using TWIRLA
      º  Stop TWIRLA if an arterial or venous thrombotic/thromboembolic event occurs
      º  Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately
      º  Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery
      º  Start TWIRLA no earlier than four weeks after delivery in women who are not breast-feeding
      º  Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy
    Arterial Events- CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (> 35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.
  • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment-

    Discontinue TWIRLA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

  • Liver Disease- Discontinue TWIRLA if jaundice develops

  • Hypertension- Monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.

  • Gallbladder Disease- Studies suggest CHCs increase risk of developing gallbladder disease and may also worsen existing gallbladder disease.

  • Adverse Carbohydrate and Lipid Metabolic Effects-
      º  TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA.
      º  Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.

  • Headache- If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA if indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).
  • Bleeding Irregularities and Amenorrhea- Women using TWIRLA may experience unscheduled bleeding, especially during the first three months of use, or experience absence of scheduled bleeding. If bleeding persists or occurs after previously regular cycles on TWIRLA, or if scheduled bleeding does not occur, evaluate for causes such as pregnancy or, in the case of unscheduled bleeding, malignancy.
  • Other Warnings and Precautions- Other warnings and precautions include, depression, cervical cancer, increased serum concentrations of binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS

The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of four VTEs in TWIRLA-treated patients were identified in the Phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.

Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA.

INDICATIONS AND USAGE

TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use:
Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2.

This is not a comprehensive list of safety information related to TWIRLA.

Please See

Full Prescribing Information

, including BOXED WARNING.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at http://www.fda.gov/medwatch or 1-800-FDA-1088.

About Agile Therapeutics, Inc.
Agile Therapeutics is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol) transdermal system is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website.

Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We may in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding market availability and uptake of Twirla, and the expected structure of our commercialization plan for Twirla among others. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to our ability to maintain regulatory approval of Twirla, the ability of our third party manufacturer, Corium, to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully commercialize and obtain market access for Twirla, the successful development of our sales and marketing capabilities, the accuracy of our estimates of the potential market for Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely upon as well as on our potential customer base, and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Contact:

Matt Riley
Head of Investor Relations & Corporate Communications
[email protected]



Posted on

Kraton Corporation Announces Proposed Private Offering of Senior Notes and Expected Conditional Full Redemption of 7.000% Senior Notes due 2025

PR Newswire

HOUSTON, Dec. 7, 2020 /PRNewswire/ — Kraton Corporation (NYSE: KRA) (the “Company”) today announced that Kraton Polymers LLC and Kraton Polymers Capital Corporation, its wholly-owned subsidiaries (together, the “Issuers”), intend to offer $400.0 million in aggregate principal amount of senior notes due 2025 (the “New Notes”), subject to market and customary conditions. The New Notes will be general unsecured obligations of the Issuers and will be guaranteed by the Company and certain of the Issuers’ wholly-owned domestic subsidiaries that guarantee the U.S. dollar denominated borrowings under the Company’s existing senior credit facilities and outstanding senior notes. 

The Issuers intend to use the net proceeds from the offering of the New Notes, together with cash on hand or borrowings under the Company’s asset-based revolving loan facility, to redeem of all of their outstanding 7.000% Senior Notes due 2025 (the “7.0% Senior Notes”) and to pay related fees and expenses of the refinancing.

Pursuant to the terms of the indenture governing the 7.0% Senior Notes, the Issuers intend to issue a conditional notice of redemption to redeem the outstanding 7.0% Senior Notes. The redemption will be conditional upon successful completion of the offering of the New Notes.

The New Notes and related guarantees will be offered, and sold, to persons reasonably believed to be qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and to persons outside of the United States pursuant to Regulation S under the Securities Act. The offer and sale of the New Notes and related guarantees have not been, and will not be, registered under the Securities Act or any state securities laws, and accordingly the New Notes and related guarantees may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or the solicitation of an offer to purchase any of the foregoing securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation, sale or purchase would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

This press release also does not constitute a notice of redemption under the optional redemption provisions of the indenture governing any series of notes.

FORWARD LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are often characterized by the use of words such as “believes,” “estimates,” “expects,” “projects,” “may,” “intends,” “plans” or “anticipates,” or by discussions of strategy, plans or intentions. The statements in this press release that are not historical statements, including statements regarding our intention to offer the New Notes and to use the proceeds therefrom to fund the redemption of the 7.0% Senior Notes, are forward-looking statements. All forward-looking statements in this press release are made based on management’s current expectations and estimates, which involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed in forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those expressed in forward-looking statements is contained in the Company’s most recently filed annual report on Form 10-K, quarterly reports on Form 10-Q and in other filings made by the Company with the U.S. Securities and Exchange Commission, and include, but are not limited to, risks related to: the Company’s ability to repay or re-finance its indebtedness; the Company’s reliance on third parties for the provision of significant operating and other services; health epidemics or pandemics such as COVID-19 (including governmental and regulatory actions relating thereto); conditions in the global economy and capital markets; fluctuations in raw material costs; limitations in the availability of raw materials; competition in the Company’s end-use markets; and other factors of which we are currently unaware or deem immaterial. Readers are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements contained herein speak only as of the date of this press release, and the Company assumes no obligation to publicly update or revise such forward-looking statements in light of new information or future events.

For Further Information:
H. Gene Shiels 281-504-4886

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kraton-corporation-announces-proposed-private-offering-of-senior-notes-and-expected-conditional-full-redemption-of-7-000-senior-notes-due-2025–301187258.html

SOURCE Kraton Corporation

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Amerant Bancorp Inc. Announces the Adjusted Price Range of its Modified Dutch Auction Tender Offer to Repurchase up to $50.0 Million of its Class B Common Stock at a price not greater than $12.55 nor less than $11.05 per share

CORAL GABLES, Fla., Dec. 07, 2020 (GLOBE NEWSWIRE) — Amerant Bancorp Inc. (NASDAQ: AMTB and AMTBB) (the “Company” or “Amerant”) announced today that it has adjusted the price range of its modified “Dutch auction” tender offer (the “Tender Offer”) to purchase, for cash, up to $50.0 million of shares of its Class B common stock (the “Class B Common Stock”) at a price per share not greater than $12.55 and not less than $11.05, less any applicable withholding taxes and without interest. The aggregate Tender Offer purchase price of up to $50.0 million remains unchanged. The expiration date of the Tender Offer also remains unchanged, and is currently scheduled for 11:59 p.m., New York City time, on December 18, 2020, unless the offer is extended or terminated. The full terms and conditions of the Tender Offer are discussed in the Offer to Purchase, dated November 20, 2020 (as previously amended and supplemented to the date hereof, “Offer to Purchase”), and the associated Letter of Transmittal and other materials relating to the Tender Offer that Amerant initially filed on November 20, 2020 (each as amended) with the Securities and Exchange Commission (the “SEC”).

When the Tender Offer expires, Amerant will determine the lowest price per Share (in increments of $0.10) within the range of prices specified above that will enable it to purchase the maximum number of shares of Class B Common Stock having an aggregate purchase price not exceeding $50.0 million (such purchase price, the “Final Purchase Price”). All shares purchased in the Tender Offer will be purchased at the same price. All shares tendered at prices higher than the purchase price will be promptly returned to shareholders. If the Tender Offer is fully subscribed, Amerant would repurchase between 30% and 34% of its issued and outstanding Class B Common Stock as of November 12, 2020, depending on the purchase price payable in the Tender Offer. In addition, in the event that shares are properly tendered at or below the purchase price (and not properly withdrawn) having an aggregate purchase price of more than $50.0 million, Amerant may exercise its right to purchase up to an additional 2% of its outstanding shares of Class B Common Stock without extending the expiration date.

All tenders of shares made prior to the Company’s announcement of the amendment of the price range of the Offer on December 7, 2020 are no longer valid. Accordingly, shareholders who have previously tendered Shares by completing and returning the original Letter of Transmittal filed on November 20, 2020, including shareholders who checked the box captioned “Shares Tendered at Price Determined Under the Offer” in the original Letter of Transmittal, and who still wish to participate in the Tender Offer, will be required to retender their Shares as provided for in the
amended and restated
Offer to Purchase, the amended and restated Letter of Transmittal and the amended and restated Notice of Guaranteed Delivery.

Tenders of shares must be made on or prior to the expiration of the Tender Offer and may be withdrawn at any time on or prior to the expiration of the Tender Offer. In addition, unless Amerant has already accepted a shareholder’s tendered shares for payment, a shareholder may withdraw tendered shares at any time after 11:59 p.m., New York City time, on January 21, 2021, the fortieth business day after the commencement of the Tender Offer.

The Tender Offer is not contingent on the receipt of financing or any minimum value of shares being tendered. The Tender Offer will, however, be subject to other conditions, which are disclosed in the Offer to Purchase. Amerant believes that a modified “Dutch auction” tender offer is an efficient mechanism that will provide shareholders with the opportunity to tender all or a portion of their shares of Class B Common Stock.

The Board of Directors has authorized the Tender Offer. However, none of the Company, the Board of Directors, the dealer manager, the information agent or the depositary are making any recommendation to shareholders as to whether to tender or refrain from tendering their shares in the Tender Offer or as to the price at which shareholders may choose to tender their shares. No person is authorized to make any such recommendation. Shareholders must decide how many shares they will tender, if any, and the price within the stated range at which they will offer their shares for purchase. In doing so, shareholders should read carefully the information in, or incorporated by reference in, the Offer to Purchase and the Letter of Transmittal (as they may be amended or supplemented), including the purpose and effects of the Tender Offer. It is recommended that shareholders discuss their decisions with their own investment and tax advisors.

Keefe, Bruyette & Woods, a Stifel Company, is acting as dealer manager and information agent for the Tender Offer, and the depositary is Computershare Trust Company, N.A. Registered holders will have access to or receive the Offer to Purchase, Letter of Transmittal and related documents. Beneficial holders will have access or receive the Offer to Purchase and a communication from their bank, broker or custodian. For questions and information, please call the information agent toll-free in the United States at (877) 821-5775 or in Venezuela at 58 212-3353038.

Certain Information Regarding the Tender Offer

The information in this press release describing the Tender Offer is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell shares of Class B Common Stock in the Tender Offer. The Tender Offer is being made only pursuant to the Offer to Purchase and the related materials that the Company has filed or is filing with the SEC, and will make available or distribute to its shareholders, as such materials may be amended or supplemented. Shareholders should read such Offer to Purchase and related materials carefully and in their entirety because they contain important information, including the various terms and conditions of the Tender Offer. Shareholders of the Company may obtain a free copy of the Tender Offer statement on Schedule TO, the Offer to Purchase and other documents that the Company has filed or is filing with the SEC from the SEC’s website at www.sec.gov. Shareholders also will be able to obtain a copy of these documents, without charge, from Keefe, Bruyette & Woods, a Stifel Company, the dealer manager and information agent for the Tender Offer, toll free in the United States at (877) 821-5775 or in Venezuela at 58 212-3353038. Shareholders should carefully read all of these materials prior to making any decision with respect to the Tender Offer.

About Amerant Bancorp Inc.

The Company is a bank holding company headquartered in Coral Gables, Florida. The Company operates through its subsidiaries, Amerant Bank, N.A. (the “Bank”), Amerant Investments, Inc., Amerant Trust, N.A. and Elant Bank and Trust Ltd. The Company provides individuals and businesses in the U.S., as well as select international clients, with deposit, credit and wealth management services. The Bank, which has operated for over 40 years, is the second largest community bank headquartered in Florida. The Bank operates 25 banking centers—18 in South Florida and 7 in the Houston, Texas area—and loan production offices in Dallas, Texas and New York, New York.

Visit our investor relations page at https://investor.amerantbank.com for additional information.

Cautionary Notice Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, including, without limitation, statements regarding the Tender Offer, as well as statements with respect to our objectives, expectations and intentions and other statements that are not historical facts. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target,” “goals,” “outlooks,” “modeled,” “create,” and other similar words and expressions of the future.

Forward-looking statements, including those as to our beliefs, plans, objectives, goals, expectations, anticipations, estimates and intentions, involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the Company’s actual results, performance, achievements, or financial condition to be materially different from future results, performance, achievements, or financial condition expressed or implied by such forward-looking statements. You should not rely on any forward-looking statements as predictions of future events. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, together with factors that include but are not limited to: the possibility that shareholders will not be receptive to the Tender Offer; the Company’s ability to consummate the Tender Offer, changes in general market, economic, tax, regulatory or industry conditions that impact the ability or willingness of the Company to consummate the Tender Offer on the terms described above or at all; credit risk; changes in market interest rates; the length and severity of the COVID-19 outbreak and its impact on the Company’s business and financial condition; economic downturn or recession; and government regulation and supervision. Additional factors that may cause actual results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, our quarterly report for the quarter ended June 30, 2020, as well as its other filings with the SEC, which are available on the SEC website at www.sec.gov. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements.

CONTACT

Investors
[email protected]
(305) 460-8728

Media
[email protected]
(305) 441-8414



Posted on

IntelliChief to Present on AP Automation and the Benefits Real-Time Integration With Infor XA During the 5th Week of the ISE Virtual Conference

Join IntelliChief, an Infor Solution Partner, on December 8th from 2-4 pm EST for a presentation, live demo, and customer Q&A covering IntelliChief’s seamless integration with Infor XA, enhancements in operational efficiency in AP, and ROI potential.

Tampa, FL, Dec. 07, 2020 (GLOBE NEWSWIRE) — IntelliChief, an Infor Solution Partner, will present on Accounts Payable Automation during the fifth week of Information Systems Engineering, Inc.’s ISE Virtual Conference. This event focuses on connecting companies that utilize Infor’s XA ERP to support business processes with Infor-approved vendors specializing in content management, business process automation, records retention, compliance, and more.

Organizations that currently depend on Infor XA to manage enterprise resources will be treated to an in-depth presentation followed by a live demo and Q&A session with one of IntelliChief’s current Infor XA customers, Teledyne Technologies.

Doing more with less has become an essential goal for businesses. By implementing AP Automation tools, your Accounts Payable department can yield significant savings. During this live webinar, IntelliChief experts will cover the various ways AP Automation impacts productivity and efficiency by exploring topics such as:

  • The importance of real-time integration with your Infor XA ERP
  • Implementing an automated matching process (2-3 or 4-way matches)
  • Develop standardized and consistent invoice processing across the department
  • Improve productivity with “Straight-Through Processing”
  • Utilize easy-to-use workflows to reduce bottlenecks and increase efficiency
  • Search for and retrieve digital documents and invoices right from your Infor XA ERP screen (no need to navigate to another software program)

During this session, you will be able to see a live demonstration of our easy-to-use automation tool. You will walk away with an in-depth understanding of how AP Automation can result in a significant return on investment for your company.

Register Here: https://register.gotowebinar.com/register/4365457397474966798

About IntelliChief

IntelliChief is the emerging leader in Enterprise Content Management (ECM) and Workflow Automation solutions. Leveraging advanced OCR, powerful workflows, document management, and analytics, IntelliChief eliminates manual processes and automates repetitive, time-consuming tasks to help businesses secure a decisive competitive advantage.

As a trusted Oracle Gold Partner and Infor Solution Partner, IntelliChief is recognized for its robust, configurable solutions and secure integrations with all ERP systems and applications. Hundreds of customers in every industry depend on IntelliChief as a strategic partner to help them digitize documents, standardize business processes, and automate Accounts Payable, Sales Orders, Human Resources, and more.

The IntelliChief team is committed to serving our customers, community, and country by guiding them through digital transformation and exemplifying what is possible with an ardent dedication to innovation and progress.

Connect with IntelliChief:

IntelliChief Resource Library | Blog | LinkedIn | Twitter 

 

For more information, visit https://www.intellichief.com/.



Zachary Leete
IntelliChief
2394049545
[email protected]

Posted on

Brickell Biotech Doses First Patient in Second U.S. Pivotal Phase 3 Clinical Study

T
opline results from
the U.S. pivotal Phase 3 program
anticipated
in
the fourth quarter of
2021

Sofpironium bromide gel, 5% (ECCLOCK

®

) recently launched in Japan by development partner, Kaken Pharmaceutical

BOULDER, Colo., Dec. 07, 2020 (GLOBE NEWSWIRE) — Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced dosing of the first patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis. Brickell’s U.S. Phase 3 program is comprised of two pivotal trials, the Cardigan I and Cardigan II studies, which are both currently enrolling patients. The Company expects to announce topline results from these two studies in the fourth quarter of 2021. If successful, the results from the studies are expected to form the basis of a prospective New Drug Application in the U.S. for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Additional details of the Cardigan II study can be found on https://clinicaltrials.gov under identifier NCT03948646.

“We are excited to announce the initiation of the Cardigan II study, which is the second trial in our U.S. pivotal Phase 3 clinical program for sofpironium bromide gel, 15%,” said Deepak Chadha, Chief Research and Development Officer of Brickell. “This marks another important milestone for the Company, and we continue to be encouraged by the progress we are making with our Phase 3 program, particularly in light of the current environment. We look forward to providing enrollment updates for the Cardigan I and II studies in the coming months.”

On November 26, 2020, Brickell’s Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”) launched commercial sales of ECCLOCK® in Japan for the once-daily treatment of primary axillary hyperhidrosis. This marks the first commercialization of sofpironium bromide worldwide. Under the sublicense agreement with Kaken, Brickell is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide gel in Japan. Furthermore, Kaken has rights to develop and commercialize sofpironium bromide in South Korea, China, and certain other Asian countries, and Brickell is entitled to receive royalties based on a percentage of Kaken’s net sales in these countries.

About Sofpironium Bromide

Sofpironium bromide is a proprietary investigational new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.

About Hyperhidrosis

Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.

About Brickell

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit https://www.brickellbio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design, progress and/or results of ongoing and future clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory submissions and approvals, and prospects for commercializing any of Brickell’s product candidates, or research collaborations with, or actions of, its partners, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential,” “look forward” and similar expressions and their variants, as they relate to Brickell, Kaken, or any of Brickell’s partners, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development, regulatory changes, supply chain disruptions, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, disruption or inability by Kaken to supply and commercialize the product in Japan, or obtain or retain adequate pricing or reimbursement, and other risks associated with developing, and obtaining regulatory approval for and commercializing product candidates.

Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at https://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

1Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.
2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.

Brickell Investor Contact:

Dan Ferry
LifeSci Advisors
(617) 430-7576
[email protected]



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VitalHub Subsidiary Transforming Systems Secured 5-Year Contract with NHS Herefordshire and Worcestershire CCG

TORONTO, Dec. 07, 2020 (GLOBE NEWSWIRE) — VitalHub Corp. (the “Company” or “VitalHub”) (TSXV: VHI) is pleased to announce that recently acquired subsidiary, Transforming Systems, has secured a 5-year recurring contract with NHS Herefordshire and Worcestershire CCG to deploy the Company’s SHREWD Resilience and Action products with partners across the region.

Prior to this 5-year, recurring revenue contract, the SHREWD platform collectively serviced 28% of the entire population of the UK. This deployment encompasses a meaningful continued expansion of SHREWD’s presence and reach within the UK health economy and will consist of a two-phased approach. The first phase is already seeing successful engagement with all system partners in Worcestershire, including the Acute Trust, Community, Ambulance and Social Care. The second phase will encompass engagements with similar partners in Herefordshire.

Located in the Midlands region of the United Kingdom, NHS Herefordshire and Worcestershire CCG is responsible for the care of a population of 800,000 individuals. The health economy has two acute hospital trusts, with three sites in Worcestershire and one in Herefordshire and represents an area with a considerably busy urgent care footprint.

By way of background, Clinical Commissioning Groups (CCGs) are responsible for overseeing the hospital and community NHS services within their local STP. The Herefordshire and Worcestershire STP comprises the following organizations:

  • NHS Herefordshire and Worcestershire CCG
  • Worcestershire Acute Hospitals NHS Trust
  • Wye Valley NHS Trust
  • Herefordshire and Worcestershire Health and Care NHS Trust
  • West Midlands Ambulance Service NHS Trust
  • Herefordshire County Council
  • Worcestershire County Council

CCG commissioning involves deciding what services are needed for diverse local populations and ensuring that they are provided. An essential challenge in successfully accomplishing this directive involved having a regional view toward understanding the demand, capacity, and performance of services and resources across the region, in order to facilitate appropriate allocation or resources, load balance, and optimized planning.

SHREWD Resilience enables the whole health and social care system within a defined area to access real-time data. Resilience displays data in a way that is simple to understand and visually identifies areas of pressure quickly, enabling operational leaders and front-line teams alike to access a real-time view of the situation in a matter of seconds.

SHREWD Action, in combination with Resilience, is a cloud-based add-on module for the SHREWD platform that allows users to easily create and manage real-time escalation and response plans for the urgent and emergency care pathway, across a whole health economy. Taken together, the SHREWD platform offers regional health systems a comprehensive solution through which they can easily and readily monitor activity across their system, in real-time.

The partnership team at Transforming Systems have forged strong relationships with the Worcestershire partners, built on local knowledge and awareness of the challenges the area faces and the opportunities that will be delivered using the SHREWD platform.

“We are delighted to have recently partnered with NHS Worcestershire & Herefordshire CCG as we understand the operational challenges they face with a considerably busy urgent care footprint caring for a population of 800,000,” said Lisa Riley, Vice President of Strategic Product and Partnership Development at Transforming Systems. “Our SHREWD Resilience and Action modules will offer the oversight and assurance required to more effectively manage their urgent and emergency care pathways, providing them with a single source of the truth and enabling them to reduce pressure, manage demand and capacity and improve patient flow across the whole health economy.”

“Governments and regional health bodies are demonstrating their need to access real-time, systems-wide operational data to help them better understand how their health economies are performing,” said Dan Matlow, CEO of VitalHub Corp. “The pandemic has significantly accelerated the need for improved resource planning and operational visibility solutions, and we are seeing a correspondingly strong increase in our recurring revenue growth as a result. We are pleased that SHREWD has established a very strong footprint across the UK, and this further regional contract deal continues our expansion and growth across this market.”

ABOUT TRANSFORMING SYSTEMS
LTD
.

In 2015, Transforming Systems began commercializing their solutions to help the NHS solve a fundamental challenge surrounding lack of access to real-time information across its multitude of services. Developed over the course of a 6-year R&D process, Transforming Systems’ product portfolio, SHREWD, aims to solve the challenge of capturing and transforming high quality data on fluctuating scales, from varying sources.

The product portfolio facilitates secure, real-time data collection, analysis and forecasting, at a price that is accessible to all health and social care commissioners. Once captured, the SHREWD Platform empowers NHS teams to determine actionable insights from a wide range of healthcare data, leading to improved organizational efficiencies and resource utilization, ultimately aiming to improve the delivery of patient care.

ABOUT VITALHUB

Software for Health and Human Services providers designed to simplify the user experience & optimize outcomes.

VitalHub provides technology to Health and Human Services providers including; Hospitals, Regional Health Authorities, Mental Health, Long Term Care, Home Health, Community and Social Services. VitalHub solutions span the categories of Electronic Health Record (EHR), Case Management, Care Coordination, Patient Flow & Operational Visibility, and DOCit Mobile Apps.

The Company has a robust two-pronged growth strategy, targeting organic growth opportunities within its product suite, and pursuing an aggressive M&A plan. Currently, VitalHub serves 275+ clients across Canada, USA, UK, Australia, Qatar, and Latvia. VitalHub is based in Toronto, Canada, with an offshore development hub in Sri Lanka. The Company is publicly traded on the TSX Venture Exchange under the symbol “VHI”.

CAUTIONARY STATEMENT

This press release includes forward-looking statements regarding the Corporation and its business, which may include, but is not limited to, statements with respect to the appointment of a new directors. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the technology industry, failure to obtain regulatory or shareholder approvals, market conditions, economic factors, the equity markets generally and risks associated with growth and competition. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Corporation undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT INFORMATION

Dan Matlow
Chief Executive Officer, Director
(416) 727-9061
[email protected]



Posted on

Kevin Muir Joins Delcath Systems, Inc. as VP, Commercial Operations

NEW YORK, Dec. 07, 2020 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced Kevin Muir has joined the company as Vice President of Commercial Operations. In his most recent role, Mr. Muir was Director of Sales for the Embolics Interventional Oncology business unit of BTG plc where he played a key role in growing that business from $40 million to $180 million at which time BTG was acquired by Boston Scientific.

Gerard Michel, CEO of Delcath, commented, “We are thrilled that Kevin is joining the Delcath team as VP of Commercial Operations. He is a seasoned and accomplished leader with experience across multiple innovative medical technologies with a recent focus in the growing field of interventional oncology. Kevin’s proven ability to both build commercial teams and introduce novel technologies into the marketplace will be a critical asset as we prepare for the launch of HEPZATO upon anticipated FDA approval. His hire is another important step in Delcath’s transition from a development to commercial stage company.”

Mr. Muir commented, “Delcath’s HEPZATO platform has the potential to make a substantial difference in the lives of the many patients who are suffering from primary or metastatic cancers of the liver. I am joining at an exciting time, with the announcement of topline data from the pivotal FOCUS trial anticipated in early 2021, followed by an expected NDA resubmission and launch in the U.S. in 2022 for the treatment of patients with hepatic dominant metastatic ocular melanoma. I look forward to leading the prelaunch planning and eventual commercialization of HEPZATO, as well as working with the broader team as we expand the platform to treat other tumor types upon execution of further clinical investigations.”

Mr. Muir joins Delcath Systems with 20 years of sales and marketing experience in the biotherapeutics and medical technology industries. Before joining Delcath, Mr. Muir was Director of U.S. Sales for the Interventional Oncology business unit at BTG, where he played a key role in the success of TheraSphere™ (custom ordered micro-embolic 90Y radiation radio isotope-therapy). Prior to that he was Director of Sales at ClearFlow Inc. and Aragon Surgical. Mr. Muir also held leadership sales roles at Kensey Nash Corporation, Kyphon, and Genzyme Biosurgery. Prior to his career in industry, Mr. Muir served as a Field Artillery officer in the U.S. Army. He completed his BS in Management Systems Engineering at the United States Military Academy at West Point where he was a member of the West Point Cadets Football Team.

About Delcath Systems, Inc.

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product, HEPZATO KIT™ (melphalan hydrochloride for injection/hepatic delivery system), is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. HEPZATO KIT has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath CHEMOSAT® Hepatic Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.

Safe Harbor / Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to the timing and results of the Company’s clinical trials and actions by the FDA or foreign regulatory agencies. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact:

Delcath Investor Relations

Email: [email protected] 

Hayden IR

James Carbonara 
(646)-755-7412 
[email protected] 



Posted on

Digihost Announces Normal Course Issuer Bid

VANCOUVER, British Columbia, Dec. 07, 2020 (GLOBE NEWSWIRE) — Digihost Technology Inc. (TSX-V: DGHI; OTCPK: HSSHF) (“Digihost” or the “Company”) is pleased to announce that it has received approval to undertake, at the Company’s discretion, a normal course issuer bid program to purchase up to 2,003,683 of its subordinate voting shares for cancellation (the “Bid”).

The Company is commencing the Bid because it believes that from time to time the market price of its subordinate voting shares may not fully reflect the underlying value of the Company’s business, and that the repurchase of its subordinate voting shares at those times would be in the best interests of its shareholders.

As of the date hereof, the Company has 40,073,661 subordinate voting shares issued and outstanding. The maximum number of subordinate voting shares that may be purchased by the Company under the Bid represents approximately 5% of the Company’s issued and outstanding shares. Shares repurchased under the Bid will be returned to treasury for cancellation. The Company received acceptance from the TSX Venture Exchange (the “TSXV”) to commence the Bid on December 10, 2020. The Bid will terminate on December 10, 2021, or on an earlier date in the event that the maximum number of common shares sought in the Bid has been repurchased. The Company reserves the right to terminate the Bid at any time.

Purchases pursuant to the Bid are expected to be made through the facilities of the TSXV, or such other permitted means (including through alternative trading systems in Canada), at prevailing market prices.

The Company has engaged Canaccord Genuity Corp. to act as the broker through which the Bid will be conducted.


About Digihost Technology Inc.

Digihost Technology Inc. is a growth-oriented blockchain company primarily focused on Bitcoin mining. The Company’s mining facility is located in Buffalo, N.Y., and is equipped with an 18.7MVA 115,000-kilovol-ampere outdoor substation with an option to increase the power output to 42MVA.


For more information, please contact:


Michel Amar, Chief Executive Officer
Telephone: 917-242-6549
Email: [email protected]

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


Cautionary Statement

Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.


Forward-Looking Statements

This news release includes forward-looking statements that are subject to risks and uncertainties. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Digihost and its investee companies to be materially different from the historical results or from any future results expressed or implied by such forward-looking statements. The information in this release about future plans and objectives of the Company, are forward-looking information. Other forward-looking information includes but is not limited to information concerning: the intentions, plans and future actions of the Company, as well as the Company’ ability to successfully mine digital currency, revenue increasing as currently anticipated, the ability to profitably liquidate current and future digital currency inventory, volatility of network difficulty and digital currency prices and the resulting significant negative impact on the Company’s operations, and the regulatory environment of cryptocurrency in the applicable jurisdictions. Although Digihost believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the forward-looking statements. Such factors include, among others, risks relating to future capital needs and uncertainty of additional financing; the competitive nature of the industry; currency exchange risks; the need for the Company to manage its planned growth and expansion; the need for continued technology change; protection of proprietary rights; network security risks; the ability of the Company to maintain properly working systems; reliance on key personnel; global economic and financial market deterioration; and volatile securities markets impacting security pricing unrelated to operating performance. In addition, particular factors which could impact future results of the business of the Company include but are not limited to: the effects on the Company of the COVID-19 crisis; ability to successfully mine digital currency; revenue may not increase as currently anticipated, or at all; it may not be possible to profitably liquidate the current digital currency inventory, or at all; a decline in digital currency prices; an increase in network difficulty; the Company may not achieve operating hash rate, power utilization, efficiencies or profitability as currently anticipated, or at all; the volatility of digital currency prices; the anticipated growth and sustainability of electricity for the purposes of cryptocurrency mining in the State of New York; the ability to complete current and future financings; any regulations or laws that will prevent the Company from operating its business; historical prices of digital currencies; an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to the effects of COVID-19 on the price of digital currencies, capital market conditions, restriction on labour and international travel and supply chains; and the ability to mine digital currencies that will be consistent with historical prices. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Digihost does not undertake to update any forward-looking information except in accordance with applicable securities laws.